High efficacy of the combination of oral vinorelbine (NVBo), capecitabine (X) and trastuzumab (H) in HER2-positive metastatic breast cancer (MBC): updated results of an international phase II trial with a median follow-up of 39 months

Background: Chemotherapy (CT) plus H is the standard
treatment for HER2-positive MBC. H plus vinorelbine combination
therapy is an active and safe regimen in the first-line setting.
The all-oral CT combination of NVBo and X has shown activity and
good tolerability in MBC. We report the latest results from a
multinational phase II study assessing the efficacy and safety of
NVBo, X and H in HER2-positive MBC after a median follow-up of 39
months.

Materials and Methods: In this multicenter trial, main
eligibility criteria included: HER2-positive disease (3+ IHC or
FISH+), documented measurable metastatic disease previously
untreated by CT, relapse ˇÝ6 months after the end of neoadjuvant or
adjuvant CT, Karnofsky PS ˇÝ70. NVBo was given as a 60 mg/m2 (cycle
1) or 80 mg/m2 (from cycle 2) dose D1 & D8 every 3 weeks, X at
1000 (750 if ˇÝ65 y) mg/m2/bid D1-D14 every 3 weeks, H at 4 mg/kg
on D1 as a loading dose then 2 mg/kg i.v. weekly starting on D8.
Treatment was continued until progression.

Conclusion: Combination chemotherapy with NVBo and X plus H
is an active first-line regimen for HER2-positive MBC. Treatment
could be continued until disease progression without a pre-planned
maximum number of cycles in many patients.

High efficacy of the combination of oral vinorelbine (NVBo), capecitabine (X) and trastuzumab (H) in HER2-positive metastatic breast cancer (MBC): updated results of an international phase II trial with a median follow-up of 39 months